Cleared Traditional

ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER

K972631 · Ics Medical Corp. · Neurology
Sep 1997
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K972631 is an FDA 510(k) clearance for the ICS MEDICAL VEMR VIDEO EYE MOVEMENT RECORDER, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Ics Medical Corp. (Schaumburg, US). The FDA issued a Cleared decision on September 22, 1997, 70 days after receiving the submission on July 14, 1997. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number K972631 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1997
Decision Date September 22, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWN — Nystagmograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1460